CLINICAL HANDBOOK OF SCHIZOPHRENIA

61. Ethics 627hospitals, and research institutions in the United States. The IRB must have at least fivemembers, and include researchers, one or more community representatives, an ethicist ora lawyer, and in some cases a statistician. The IRB reviews the research protocol, the investigator’sbrochure related to any study drugs, and the informed consent form to determinestudy acceptability. While the purview of the IRB includes both ethical and scientificissues, the review of scientific issues may be delegated to another more qualified body(e.g., an NIH [National Institutes of Health] Study Section).In its review, the IRB ensures that the study complies with relevant regulations andguidelines (Emanuel, Wendler, & Grady, 2000). In the United States, all human subjectresearch funded by the Federal government, or conducted at an institution that receivesFederal funds, must comply with the Federal Common Rule (Title 45 CFR Part 46).Other regulations define additional protections for pregnant women (referred to asSubpart B regulations), prisoners (Subpart C), and children (Subpart D). Despite repeatedcalls over the last 20 years, Federal regulations do not define additional protections forincapable adults, including those incapacitated by mental illness (Karlawish, 2006).Other relevant guidelines for clinical research include the World Medical Association’sDeclaration of Helsinki, the Council for International Organizations of Medical Sciences’International Ethical Guidelines for Biomedical Research Involving Human Subjects, andthe International Conference on Harmonization’s Good Clinical Practice guidelines. Relevantregulations and guidelines, guidance, and educational materials are found at thewebsite of the Office for Human Research Protection (www.hhs.gov/ohrp).Clinical research is governed by three ethical principles: respect for persons; beneficence;and justice (Table 61.1). The principle of respect for persons means that the wishesof autonomous individuals ought to be taken seriously, and that persons incapable ofautonomous choice are entitled to protection. It grounds requirements for free and informedconsent from research participants and confidentiality of research information.The principle of beneficence signifies that one must protect people from harm and, wherepossible, promote their benefit. It underpins the requirement that the benefits and harmsof research participation stand in reasonable relation. The principle of justice implies thatone must treat people fairly. It is the basis for the requirement that study selection proceduresmust be fair, neither unduly advantaging nor disadvantaging any relevant group ofpotential study participants.The free and informed consent of research subjects must generally be sought prior tostudy participation. Prospective subjects must be informed of the purpose of the study,duration of participation, procedures to be administered, the benefits and harms of studyparticipation, alternatives, and their rights as research subjects. A distinction may bedrawn between the consent process and the consent form. The consent process is the ethicallymandated dialogue between the clinical investigator and the prospective study par-TABLE 61.1. Moral Principles and Rules for Clinical ResearchMoral principleRespect for personsBeneficenceJusticeMoral rule• Obtain the free and informed consent of prospective research subjects.• Protect the confidentiality of private information.• Therapeutic procedures must satisfy clinical equipoise.• Risks of nontherapeutic procedures must be (1) minimized and (2)reasonable in relation to knowledge to be gained.• Subject selection procedures must be fair.